Status:
COMPLETED
Dietary Supplement With and Without a Probiotic
Lead Sponsor:
Prolacta Bioscience
Conditions:
Healthy Adult Subjects
Eligibility:
All Genders
18-44 years
Phase:
NA
Brief Summary
Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonizat...
Detailed Description
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastroint...
Eligibility Criteria
Inclusion
- Healthy adults between the ages of 18-44 years
- Willingness to complete all study procedures and clinic visits, and provide required samples
- Provides informed consent
Exclusion
- Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
- Subjects with history of lactose intolerance
- Subjects who are on a PPI regimen
- Subjects who have taken a probiotic during the previous 30 days, or intends to take a probiotic during the study.
- Subjects who have taken antibiotics within 120 days
- Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening
- Unstable medical condition, in the opinion of the investigator
- Clinically significant abnormal laboratory test results at screening
- Participation in a clinical research trial within 30 days prior to screening
- Unable to give informed consent
- Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04433208
Start Date
March 13 2020
End Date
December 2 2020
Last Update
March 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
WCCT Global
Cypress, California, United States, 90630